ClinicalTrials.gg
RecruitingNCT06722508Updated Sep 11, 2026

Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients

An interventional study of exercise and nutritional prehabilitation in Head Cancer, Neck Cancer and Sarcopenia, sponsored by University of California, Davis. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2024, registered Nov 2024).
  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,314 studies in Head and Neck Neoplasms with a site in United States — 186 open to participants now, 283 under way, 14 of them phase 3. Head and Neck Neoplasms · United States.

Planned enrollment
731st of 1,071
20 · median 36
Started
2024
with 42 others
No phase
258 of 1,314
53 open now
Primary completion
2026-12
later than 64 of 280 live
Registered
1,212th of 1,314
by date

Among the 1,314 studies in Head and Neck Neoplasms with a site in United States, this one is the 731st largest by planned enrollment of the 1,071 interventional ones that give a count, is one of 43 that started in 2024, is one of 258 with no phase, reaches primary completion later than 64 of the 280 other live ones, and was the 1,212th registered.

Head and Neck Neoplasms

2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.

This study's planned enrollment of 20 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Open to participants now

186 of the 1,314 studies in Head and Neck Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.

All 186 open studies →

Who these studies take

Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,314 studies in Head and Neck Neoplasms with a site in United States, or all of them as a file.
02

Study summary

This study examines the acceptability, feasibility, and safety in developing a prehabilitation program for head and neck cancer patients. The purpose of this research is to access the safety and acceptability of using a prehabilitation program before head and neck cancer surgery.

Read the detailed description

The purpose of this research is to access the safety and acceptability of using a prehabilitation program before head and neck cancer surgery. In this unblinded prospective study we will establish a 2-week prehabilitation program and assess whether this is feasible, acceptable to our patients, and safe. Subjects will be enrolled through August 2025, with a goal of enrolling 20 total subjects. The anticipated duration of each subject's involvement will be approximately 3 months, beginning at the time of their initial consultation and ending approximately 1 month after surgery.

Subjects will sign the informed consent form at initial visit and then receive a 2-week home- based exercise program to follow for the two weeks leading up to their surgical date. This exercise program will be provided both electronically through a link to our study-specific Med Bridge Program. Additionally, a hard-copy/PDF will be provided to the patients who prefer this format. Nutritional goals will be suggested, mainly with protein macronutrient goals defined as at least 1.2-2g/kg of protein per day.

At initial visit and the 1-month post-op visit, Timed Up and Go (TUG) and 6 Minute walk Test (6MWT) will be evaluated.

Subjects will begin the exercise program exactly two weeks (14 days) prior to surgery and will be instructed on their "start date" as soon as a surgical date is secured. Subjects will receive all necessary equipment (pedometer, resistance bands) from the study team, as well as a log-book for recording their compliance. The PI or designated study team-member will confirm with the subject this start-date, and perform weekly follow-up calls on day 7 and day 14 to monitor for any adverse events and compliance. Any report of increased pain related to the exercise program or injury will result in immediate recommendation for medical assessment and withdrawal from the study.

Standard-of-care cancer care will otherwise take place during the prehabilitation period, including any necessary laboratory and imaging testing. No additional testing will be required of the patient. Typically, patients are seen in an initial consultation and if surgery is recommended, preoperative labs and imaging are ordered if clinically necessary. Surgery date is typically within 3-4 weeks of initial consultation. If patients screen positive for malnutrition on the Malnutrition Screening Tool, standard-of-care referral to a dietician will be recommended.

Subjects will otherwise also have their usual post-operative and post-discharge care with their provider and have their final study-related visit approximately 1 month after surgery.

Primary end-point will be to assess the feasibility, acceptability, and safety of this program.2,3

- Safety will be monitored throughout the study period, including during the prehabilitation period with a study member calling the patient weekly (Day 7 and Day 14 or prehabilitation).

03

Conditions studied

  • Head Cancer
  • Neck Cancer
  • Sarcopenia
  • Head and Neck Cancer

Keywords

  • Exercise
  • Nutritional
  • Prehabilitation
  • Head
  • Neck
  • Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

New head and neck cancer diagnosis Age > 18

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment for head and neck cancer (surgery and/or radiation)
  2. Acute or unstable cardiac conditions (unstable angina or symptomatic severe aortic stenosis)
  3. physical status of 4 and 5
  4. Disabling orthopedic or neuromuscular disease
  5. Cardiac failure ( functional classes III and IV)
  6. Severe
  7. End-stage liver or kidney disease
  8. Inability to swallow and/or feeding tube dependence
  9. Any other comorbid medical, physical, and/or mental condition that contraindicates exercise or oral nutrition
  10. Adults unable to consent
  11. Age 17.99 or younger
  12. Prisoners, pregnant women, or other vulnerable population
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    behavioral intervention

    The study involves a behavioral intervention (exercise and nutritional prehabilitation) designed to assess outcomes related to feasibility, acceptability, and safety in head and neck cancer patients. Outcomes are being measured following the intervention over a defined period (from diagnosis through 1-month post-surgery).

    Behavioral: exercise and nutritional prehabilitation

Interventions

  • Behavioralexercise and nutritional prehabilitation

    The study involves a behavioral intervention (exercise and nutritional prehabilitation) designed to assess outcomes related to feasibility, acceptability, and safety in head and neck cancer patients. Outcomes are being measured following the intervention over a defined period (from diagnosis through 1-month post-surgery).

06

What researchers measure

Primary outcomes

  1. Completion Rate of 2-Week Prehabilitation Program

    Percentage of participants who successfully complete the 2-week prehabilitation program for head and neck cancer patients.

    Time frame: 2 weeks

  2. Participant Safety During the 2-Week Program

    Number of participants who experience adverse events during the 2-week prehabilitation program, assessed using CTCAE v5.0 criteria.

    Time frame: 2 weeks

  3. Acceptability of the Program

    Number of participants who rate the prehabilitation program as acceptable, using a 5-point Likert scale (1 = Not Acceptable, 5 = Very Acceptable).

    Time frame: 2 weeks

  4. Feasibility of the Program

    Percentage of planned exercise and nutrition activities completed by participants during the 2-week prehabilitation program.

    Time frame: 2 weeks

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Powell R, Davies A, Rowlinson-Groves K, French DP, Moore J, Merchant Z. Acceptability of prehabilitation for cancer surgery: a multi-perspective qualitative investigation of patient and 'clinician' experiences. BMC Cancer. 2023 Aug 11;23(1):744. doi: 10.1186/s12885-023-10986-0. PubMed 37568097 ↗
  • Knols R, Aaronson NK, Uebelhart D, Fransen J, Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. J Clin Oncol. 2005 Jun 1;23(16):3830-42. doi: 10.1200/JCO.2005.02.148. PubMed 15923576 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.

Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 31 months is close to that.

Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2024
First posted
Dec 9, 2024
StartActual
May 9, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06722508
Responsible party
Sponsor
First posted
Dec 9, 2024
Start date
May 9, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 11, 2026

Study contacts

Randev Sandhu CRC Supervisor, BS
Contact
rssandhu@ucdavis.edu
9167342863
Marianne Abouyared PI, MD
Contact
mabouyared@ucdavis.edu
9167342801
Marianne S Abouyared, MD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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